{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "176976", "product_res_number": "Z-0393-2020", "event_date_initiated": "2018-09-27", "event_date_created": "2019-11-14", "recall_status": "Terminated", "event_date_terminated": "2022-02-01", "res_event_number": "84004", "product_code": "JDW", "k_numbers": [ "K955848" ], "product_description": "ORTHOFIX Catalogue Number: ref: 99-92504, PREFIX II ANKLE COMPLETE KIT STERILE, RX ONLY, UDI: (01)18033509855979", "code_info": "Lot # B1207288, B1215312, B1228971, B1233730   *Not marketed in US", "firm_fei_number": "3002807827", "recalling_firm": "Orthofix Srl", "address_1": "Via Delle Nazioni 9 O 73 9 via delle nazioni", "address_2": "O 73", "city": "Veronaverona", "country": "Italy", "reason_for_recall": "As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance.", "root_cause_description": "Device Design", "action": "On 10/01/2018, Orthofix provided distributor, doctors, and hospitals a urgent medical device recall notification via FedEx overnight carrier . The letter asked consignees to take the following actions:\n\n1. Immediately cease any further distribution of the affected devices;\n2. Notify hospitals, surgeons and others to whom you may have distributed affected devices that such devices cannot be used and must be returned to Orthofix according to the instructions below;\n3. Complete the Acknowledgement Form indicating that you have received this notification. It should be returned by email or fax to the contact details on the attached form.\n\n4. Subsequent Distribution: If your firm has provided or sold the affected products to other users, please provide a list of those users to the undersigned and forward this notification to them to assure prompt action.\n\n5. Product Return Instructions: To return the devices affected by this action, please follow these instructions:\nA - \tCheck your inventory for the devices affected by this action;\nB -\tComplete the attached Acknowledgement Form with the quantity you are returning;\nC -\tContact Orthofix Customer Service at (800) 266-3349 for return instructions and replacement information", "distribution_pattern": "US: AZ, CA,FL,GA,HI,IA,IL,IN,KY,LA,MD,MI,MO,MS,NC,NY,OH,OK,OR,PA,SC,TN,TX,UT,VA,WA, WI, WV, Puerto Rico \nOUS: Kuwait, Australia, Saudi Arabia, United Arab Emirates, Ireland, Japan, Spain, Poland, Switzerland, Singapore, Peru, Brazil, Germany, Great Britain, France, Italy, Australia, South Africa, Belgium, Chile, The Netherlands, Lithuania, Sri Lanka, Denmark, Israel", "openfda": { "k_number": [ "K875012", "K982068", "K861766", "K213874", "K053513", "K210784", "K001228", "K023921", "K260073", "K032532", "K875022", "K150661", "K840286", "K955848", "K120871", "K071540", "K993910", "K011136", "K241357", "K011137", "K964893", "K875013", "K040765", "K163487", "K023134", "K102777", "K903261", "K991649", "K223112", "K974911", "K963433", "K952640", "K875021", "K002605", "K021182", "K974186", "K781251", "K945670", "K994143", "K031154", "K990353", "K061493", "K970097", "K946228", "K895173", "K961920", "K061599", "K932349", "K211508", "K955780", "K140875", "K981716", "K130298", "K061498", "K905336", "K200933", "K954630", "K881511", "K001886", "K250316", "K992970", "K970751", "K003131", "K083144", "K072710", "K963973", "K905347", "K012270", "K001720", "K033289", "K011319", "K833907", "K030336", "K191803", "K051740", "K760454", "K131459", "K983757", "K950009", "K905344", "K182171", "K003294", "K192768", "K103001", "K132820", "K980788", "K970713", "K960023", "K982931", "K100414", "K842293", "K903266", "K011875", "K020097" ], "device_name": "Pin, Fixation, Threaded", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3040", "device_class": "2", 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